Assistant Regulatory Affairs
7 days ago
Assistant Regulatory Affairs & Quality Assurance Manager The Assistant Regulatory Affairs & Quality Assurance Manager will play a key role in managing all regulatory activities related to the registration, approval, and lifecycle maintenance of products in the Hong King market. This position requires close collaboration with global manufacturers, internal cross-functional teams, and regulatory authorities to ensure compliance with evolving regulatory requirements and timely product approvals. Key Responsibilities Lead the preparation, compilation, and submission of registration dossiers to the Hong King Department of Health. Conduct in-depth reviews of technical, clinical, and quality documentation provided by manufacturers. Ensure all dossiers meet current regulatory guidelines, standards, and local requirements. Collaborate with manufacturing partners to gather accurate and complete regulatory documentation. Review and align product information, Certificates of Analysis (COAs), stability data, and analytical comparability reports. Regulatory Compliance Interpret and implement the latest local regulations and guidance documents for biosimilars. Monitor regulatory changes and provide internal updates to ensure continued compliance. Authority Interaction Manage direct communication with the Department of Health and respond to deficiency letters or inquiries in a timely manner. Attend briefings, stakeholder consultations, and training sessions hosted by regulatory authorities. Labelling & Documentation Ensure local labeling compliance including accurate bilingual (English + Traditional Chinese) translations and format alignment with Hong King’s regulatory standards. Maintain up-to-date knowledge of interchangeability and pharmacovigilance requirements. Regulatory Strategy & Lifecycle Support Support regulatory strategy development for new product launches and variations (e.g., renewals, line extensions, post-approval changes). Contribute to the creation of submission plans, timelines, and risk assessments. Documentation & Recordkeeping Maintain meticulous records of submissions, approvals, correspondences, and post-approval commitments. Draft and manage Hong King-specific SOPs related to regulatory filings and submissions. Requirements 3–5 years of hands‑on regulatory affairs experience in the pharmaceutical or biopharmaceutical industry. Sound understanding of Hong King’s regulatory requirements. Experience in preparing and submitting dossiers. Strong coordination skills with external partners, contract manufacturers, and CROs. Excellent written and verbal communication skills in English. Proficiency in Cantonese is essential; Mandarin is a plus. High attention to detail, problem‑solving mindset, and strong organizational skills. Experience in team management and leadership skills. Ability to manage multiple projects and work in a dynamic, deadline‑driven environment. Knowledge of biosimilar product registration is an added advantage. Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
-
Associate Director, Regulatory Affairs
1 day ago
Hong Kong Island, Hong Kong SAR China Michael Page International (HK) Ltd Full timeAssociate Director, Regulatory Affairs - Biotech Looking for an experienced Associate Director, Regulatory Affairs to lead regulatory strategies and submissions for cutting-edge biotech products. This role offers high visibility and the opportunity to shape regulatory pathways in a dynamic, fast-growing organization. Our client is a leading biotech company...
-
Regulatory Affairs Partner
2 weeks ago
Hong Kong Island, Hong Kong SAR China F. Hoffmann-La Roche Gruppe Full timeAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
-
Regulatory Affairs Partner
2 weeks ago
Hong Kong Island, Hong Kong SAR China F. Hoffmann-La Roche Gruppe Full timeA leading global healthcare company in Hong Kong is seeking a Regulatory Affairs Partner to drive regulatory strategies and ensure compliance for their products. With over 5 years of regulatory affairs experience in Hong Kong, the ideal candidate will work across functions to navigate the evolving regulatory landscape and accelerate patient access to...
-
Senior Specialist, Regulatory Affairs
1 day ago
hong kong, Hong Kong SAR China Teva Pharmaceuticals Full timeJoin to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals 2 days ago Be among the first 25 applicants Join to apply for the Senior Regulatory Affairs Specialist role at Teva Pharmaceuticals Get AI-powered advice on this job and more exclusive features. Who We AreTogether, we’re on a mission to make good health more affordable...
-
Regulatory Affairs
7 days ago
Hong Kong Island, Hong Kong SAR China Chemill Pharma Ltd. Full timeA pharmaceutical company in Hong Kong seeks an Assistant Regulatory Affairs & Quality Assurance Manager. The role includes managing regulatory activities for product approvals and compliance. Candidates should have 3-5 years of regulatory experience, strong coordination, and communication skills in English and Cantonese. This full-time position offers...
-
Associate Director, Regulatory Affairs
1 day ago
Hong Kong Island, Hong Kong SAR China Michael Page International (Hong Kong) Limited Full timeLead Regulatory Strategy For Innovative Biotech Products Drive Regional Regulatory Submissions About Our Client Our client is a leading biotech company specializing in innovative therapies that improve patient outcomes. With a team of around 150 professionals primarily based in China and a lean, agile structure in Hong Kong, they are committed to advancing...
-
Regulatory Affairs and Quality Specialist
5 days ago
Hong Kong Island, Hong Kong SAR China Links International Full timeRegulatory Affairs and Quality Specialist Join to apply for the Regulatory Affairs and Quality Specialist role at Links International . Our client is a global leader in medical technology, committed to delivering safe and effective solutions that improve patient outcomes. They are expanding their Hong Kong team and seeking a Regulatory & Quality Compliance...
-
Regulatory Affairs
2 weeks ago
Hong Kong Island, Hong Kong SAR China Projob21.com Ltd. Full timeRegulatory Affairs & Central Compliance Senior Manager Oversight Regulatory Affairs & Central Compliance Excellent job security and worklife balance Our Client Searching for Regulatory Central Compliance Senior Manager with one of the most established Global Private Bank with 250 employees+ in North Asia Branch and operations in over 20 locations. Job Duties...
-
Biotech Regulatory Affairs Lead – Asia
1 day ago
Hong Kong Island, Hong Kong SAR China Michael Page International (HK) Ltd Full timeA leading biotech company in Hong Kong seeks an experienced Associate Director, Regulatory Affairs to shape regulatory strategies and submissions for innovative biotech products. This pivotal role involves working closely with regulatory agencies and cross-functional teams to ensure compliance and drive the company’s growth. Candidates should have a strong...
-
Hong Kong Island, Hong Kong SAR China Michael Page International (Hong Kong) Limited Full timeA leading biotech company in Hong Kong is seeking an Associate Director of Regulatory Affairs to develop and execute regulatory strategies. In this high-impact role, you will lead submissions, manage health authority interactions, and ensure compliance with evolving regulations. The ideal candidate has a strong regulatory background in biotech or...
